Philadelphia Biologics Center: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Philadelphia Biologics Center” (first 1982, latest 1984), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 82 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 4 | 4 |
| FMF | Syringe, Piston | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
Review panels
- General Hospital (11)
Most recent Philadelphia Biologics Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841717 | INTRAVENOUS INJECTION SET | FPA | 1984-07-23 | 89 |
| K834256 | PBC SYRINGE IRRIGATING | FMF | 1984-03-23 | 107 |
| K834255 | PBC SCALP VEIN SET | FOZ | 1984-03-12 | 96 |
| K834254 | PBC IV SET VENTED | FPA | 1984-02-27 | 82 |
| K834253 | PBC IV SET NON-VENTED | FPA | 1984-02-27 | 82 |
| K834252 | PBC EXTENSION SET | FPA | 1984-02-27 | 82 |
| K820911 | PBC NEEDLE BY NIPRO MED. INDUSTRIES | FMI | 1982-04-15 | 14 |
| K813649 | PBC NEEDLE | FMI | 1982-01-28 | 28 |
| K813648 | JMS NEEDLE & MAC JECT | FMI | 1982-01-28 | 28 |
| K813646 | JMS DISPOSABLE SYRINGE | FMF | 1982-01-28 | 28 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Philadelphia Biologics Center.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Philadelphia Medical Specialties (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Philadelphia Biologics Center?
FDA lists 11 510(k) clearances under the applicant name “Philadelphia Biologics Center” (first 1982, latest 1984), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Philadelphia Biologics Center?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philadelphia Biologics Center is 82 days.
Which FDA product codes appear under Philadelphia Biologics Center?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 4); FMF (Syringe, Piston, 3); FMI (Needle, Hypodermic, Single Lumen, 3).
Next steps
- See all 11 Philadelphia Biologics Center clearances with predicates and recalls
- Run predicate analysis for product code FPA, Philadelphia Biologics Center's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.